Pain Terminator Extra Strength Pain Relief Drug Recall
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. The hazard is a manufacturing practice deviation without evidence of actual product harm or contamination. Class II recalls without health outcome reports typically fall into the Moderate category.
Plain-English summary
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief tablets (containing aspirin 162 mg, acetaminophen 110 mg, caffeine 32.4 mg, and salicylamide 152 mg) distributed in 2-tablet packets. The product was manufactured for Tellus Medical Products, Palm Desert, California, with NDC number 69103-2507.
The recall was initiated on January 24, 2022, due to cGMP deviations identified during manufacturing. The affected lot is AK9451 with an expiration date of January 2022. Approximately 1,188,280 packets were distributed nationwide within the United States.
Consumers who have purchased this product should stop using it. The recall was voluntary and initiated by the firm with notification by letter. The FDA classified this as a Class II recall. The recall status was terminated on October 16, 2023.
The recalled product
- Product
- PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 1,188,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: AK9451
- Exp. Date 01/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 56 products in this recall →Related recalls
Same manufacturer · Ultra Seal Corporation
See all →- ModeratePEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateCold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateLite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExtra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19