Cough syrup recalls have been in the news lately, with several brands pulled from store shelves due to concerns over contamination or unsafe ingredients. When a recall occurs, it’s important for consumers to check whether they have the affected products at home and stop using them immediately.
Recent Cough Syrup Recalls
Some of the most notable recent recalls of cough syrups include:
- January 2023 – Several batches of Robitussin and Dimetapp cough syrups were recalled due to incorrect dosing cups that accompanied the oral syrups. The cups had incorrect markings that could potentially lead to overdose if caregivers measured the dose incorrectly.
- May 2022 – Perrigo Company issued a voluntary nationwide recall of three lots of its infants’ ibuprofen oral suspension drops due to the possibility they contained dangerously high levels of ibuprofen.
- March 2022 – Two lots of cough syrup manufactured by Advantage Dose LLC were found to be superpotent, containing higher levels of guaifenesin than indicated. This posed a risk of overdose.
- October 2021 – Marksans Pharma Limited recalled 12,288 bottles of its cough syrup in the US market due to microbiological contamination.
These are just some of the more high-profile recalls that have made headlines lately. Numerous other smaller recalls of cough syrups happen routinely that don’t gain as much public attention.
Reasons for Cough Syrup Recalls
There are a few main reasons why a cough syrup may get recalled by the manufacturer or FDA:
- Microbial contamination – Bacteria like Burkholderia contaminans or other microbes that contaminate the product during manufacturing can cause infections if the contaminated syrup is consumed.
- Incorrect ingredients or dosing – Manufacturing errors could result in a product being far more potent than it should be. Toxic levels of ingredients like acetaminophen or guaifenesin could harm those who take it.
- Packaging defects – Issues with packaging such as incorrect dosing cups or illegible ingredient labels increase the risks of a user accidentally taking too much.
- Substandard manufacturing – Poor manufacturing practices like unsanitary equipment can compromise the quality and safety of the final products.
When any of these issues are detected, brands will usually issue a voluntary recall and notify retailers to remove the products from shelves. Recalls help prevent further harm but don’t always catch every contaminated product already out there.
How Recalls are Announced
There are a few main ways that consumers may learn about a recall of a cough syrup or other over-the-counter medication:
- Manufacturer announcement – The company issuing the recall will publish a notice on their website, send out press releases, and notify retailers.
- FDA recall announcement – The FDA also publishes and updates a list of recalled products on their website.
- Pharmacy or retail notices – Local pharmacies like CVS, Walgreens, etc. may post notices about recalled products they carried.
- News media – Journalists often report on major consumer product recalls, including cough syrup.
- Social media – Brands and regulatory agencies may also announce recalls via Facebook, Twitter or other social platforms.
Regardless of the channel, the announcement will typically include details like the product name, batch numbers, UPC codes, expiration dates, and reason for recall. Consumers should check this against any of the same products they have at home.
What to Do During a Cough Syrup Recall
If you learn that a cough syrup you have at home has been recalled, you should:
- Stop using it immediately – Even if you don’t notice any issues with the recalled product, you should err on the side of safety and cease use once a recall is issued.
- Check Active Ingredients – The recall announcement should list the product details. Compare your bottle/box and verify it has the same ingredients, manufacturer details, batch numbers, etc. as the recalled items.
- Call your pharmacy – If you purchased the recalled cough syrup from a local pharmacy, contact them to see if they can confirm whether your specific product was affected or not.
- Return it for a refund – Most retailers and pharmacies will let you return recalled products for a full refund, even without a receipt in some cases.
- Seek medical help if needed – If you took the recalled medicine and are experiencing concerning symptoms like a high fever, contact your doctor or poison control.
Following a recall, it’s typically best to switch to a different brand or OTC medication altogether to be on the safe side. You can report any adverse events from the recalled product to the FDA’s MedWatch program.
Recent Major Recalls
Here is more detail on some of the most significant cough syrup recalls in the US over the past couple years:
Robitussin and Dimetapp – January 2023
In January 2023, Pfizer issued a voluntary recall for two of its popular OTC cough syrup brands – Robitussin and Dimetapp. The recall affected five batches of syrups produced between February and September 2022. This included:
- Children’s Dimetapp Cold & Cough – two recalled batches
- Children’s Robitussin Cold Cough and Flu – one recalled batch
- Children’s Robitussin Honey Cough and Chest Congestion DM – two recalled batches
The reason for the recall was that the included dosing cups had incorrect markings. They posed a risk of accidental overdose if caregivers measured the wrong dose amount when giving it to children. The company stated that they had received ten reports of incorrect dosing cup markings but no reports of adverse events so far.
Retailers were instructed to remove recalled products, and consumers who had the affected batches were advised to stop use immediately. Pfizer offered reimbursements for any recalled products returned through their website or by contacting customer service.
Perrigo Infants’ Ibuprofen – May 2022
In May 2022, Perrigo Company plc announced it was recalling three batches of its infants’ ibuprofen oral suspension drops sold at Walmart, CVS Pharmacy and Family Dollar. The affected OTC medication was labeled for children ages 6 months and older.
Lab testing revealed that the recalled products potentially contained higher ibuprofen concentrations than advertised. Too much ibuprofen can cause permanent kidney damage in infants. The recalled batches were:
| Product Name | NDC Code | Batch Number |
|---|---|---|
| Infants’ Ibuprofen Oral Suspension Drops, Concentrated, Dye-Free, Berry Flavor | 59074-0686-47 | S79129 |
| Infants’ Ibuprofen Oral Suspension Drops, Concentrated, Dye-Free, Berry Flavor | 59779-925-23 | S79129 |
| Equate Infants’ Ibuprofen Oral Suspension Drops, Concentrated, Dye-Free, Berry Flavor | 49035-125-23 | S79129 |
The manufacturer warned consumers who had purchased the recalled batches to discontinue use even if the infants did not show any signs or symptoms. They advised contacting a doctor as soon as possible if a child had taken the medicine and seemed unwell.
Advantage Dose LLC Cough Syrup – March 2022
Advantage Dose LLC issued a voluntary recall of two lots of cough syrup in March 2022 after discovering a manufacturing error had caused the products to become superpotent. The affected products were:
- Efficacy Liquid Cough Syrup Antihistamine + Expectorant + Alcohol Free Grape Flavor 4 FL OZ
- Efficacy Liquid Cough Syrup Guaifenesin + Dextromethorphan + Alcohol Free Cherry Flavor 4 FL OZ
The grape flavor syrup was later found to contain almost five times the acceptable daily intake limit for guaifenesin. The cherry flavor had over 26 times the daily limit.
These excessive guaifenesin levels posed a significant risk of overdose in adults and children over 6 years old. Side effects could potentially include impaired motor skills, dizziness, sedation, nausea, vomiting, and tachycardia.
Only certain batches with the lot codes KL180157J-A and KL180157J-B were affected. All distributors and retailers who had received the batches were notified and asked to quarantine the inventory immediately.
How Recalls Can Be Avoided
While manufacturing errors can occasionally occur even with the strictest standards, there are some things pharmaceutical companies can do to minimize risks and prevent recalls:
- Implement a strong quality management system and test frequently during production.
- Validate equipment and processes routinely to ensure they remain in control.
- Use globally accredited suppliers for ingredients and components.
- Perform stability studies on products to guarantee potency and efficacy over shelf life.
- Test final products extensively to confirm identity, strength, purity, quality, and lack of contamination.
- Establish robust track and trace systems and unique batch numbering.
- Audit factories regularly for GMP compliance and take corrective actions for any deficiencies.
Following cGMP guidelines helps manufacturers deliver consistent, high-quality medicines to consumers and protects patients from potential harm of substandard products.
Conclusion
Cough syrup recalls occur every year due to risks of contamination, incorrect dosing, formulation issues and other problems. When recalls happen, it’s vital that consumers check if any products in their home are affected and immediately discontinue use. Following the manufacturer or FDA guidance on any recalled cough syrup can help minimize risks. Being aware of recent recalls and staying vigilant about cough medicine safety is important, especially for caregivers of infants and young children.
